Associate Data Manager, Clinical Data Sciences

Job Description:

Responsibilities

• Engage in Data Monitoring and Management (DMM) activities, including data review, query management, and investigating logic check flags. 
• Ensure the quality of database design through documentation, testing, validation, and implementation of clinical data collection tools or systems. 
• Serve as the first Point of Contact for customers needing assistance with Clinical Trial Management System (CTMS) questions and issues. 
• Adhere to applicable Standard Operating Procedures (SOPs) and working practices. 
• Collaborate with Study Team Points of Contact, Document Owners, and Trial Master File (TMF) Study Owners to resolve document-related discrepancies and issues. 
• Contribute to process improvement initiatives and additional projects as they arise. 

Qualification & Expeirence

• BA/BS with any years of experience
• Demonstrated experience of ICH/GCP (International Council for Harmonization/Good Clinical Practice) documentation requirements
• Hands-on experience with electronic documentation management systems and/or web-based data management systems
• Awareness of the clinical development process, including a deep understanding of the principles of Good Clinical Practice
• Solid grasp of regulatory requirements and relevant data standards
• Strong oral and written English communication skills
• Proficiency in Microsoft Office Suite.